Trial · NCT01052428

Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)

NCT01052428, Phase 2, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2012-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease). Trials, record NCT01052428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01052428

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
NCT number: NCT01052428
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 38 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Mitral Regurgitation
Interventions: metoprolol succinate (Toprol XL), Placebo
First posted: 2010-01-20
Last updated: 2012-11-22
Results first posted: 2012-04-16

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Left Ventricular End Diastolic Volume Indexed to Body Surface Area	5 visits per Participant over 2 years (about every 6 months)	Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.
Primary	Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume	5 visits per Participant over 2 years (about every 6 months)	Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.
Primary	Left Ventricular End-Diastolic Radius to Wall Thickness	5 visits per Participant over 2 years (about every 6 months)	Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.
Primary	Left Ventricular End Systolic Volume Indexed to Body Surface Area	5 visits per Participant over 2 years (about every 6 months)	Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.
Primary	Left Ventricular Ejection Fraction	5 visits per Participant over 2 years (about every 6 months)	Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.
Primary	Systolic Longitudinal Strain	5 visits per Participant over 2 years (about every 6 months)	Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.
Primary	Peak Early Filling Rate: Rate of Change Over Time	5 visits per Participant over 2 years (about every 6 months)	Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Left Ventricular End Diastolic Volume Indexed to Body Surface Area	5 visits per Participant over 2 years (about every 6 months)	intent to treat	ml/m^2	MEAN
PRIMARY	Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume	5 visits per Participant over 2 years (about every 6 months)	intent to treat	g/ml	MEAN
PRIMARY	Left Ventricular End-Diastolic Radius to Wall Thickness	5 visits per Participant over 2 years (about every 6 months)	intent to treat	unitless	MEAN
PRIMARY	Left Ventricular End Systolic Volume Indexed to Body Surface Area	5 visits per Participant over 2 years (about every 6 months)	intent to treat	ml/m^2	MEAN
PRIMARY	Left Ventricular Ejection Fraction	5 visits per Participant over 2 years (about every 6 months)	intent to treat	percent	MEAN
PRIMARY	Systolic Longitudinal Strain	5 visits per Participant over 2 years (about every 6 months)	intent to treat	percent/%Systolic interval	MEAN
PRIMARY	Peak Early Filling Rate: Rate of Change Over Time	5 visits per Participant over 2 years (about every 6 months)	intent to treat	EDV/sec	MEAN

Source ClinicalTrials.gov

Results by group126

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Placebo	Month 0 (n=19,19)	91.66	Standard Deviation 16.48	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Toprol XL	Month 0 (n=19,19)	95.74	Standard Deviation 19.89	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Placebo	Month 3 (n=1,0)	90.93	Standard Deviation NA	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Toprol XL	Month 3 (n=1,0)	NA	Standard Deviation NA	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Placebo	Month 6 (n=17,19)	90.84	Standard Deviation 16.39	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Toprol XL	Month 6 (n=17,19)	95.24	Standard Deviation 18.52	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Placebo	Month 9 (n=1,0)	70.56	Standard Deviation NA	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Toprol XL	Month 9 (n=1,0)	NA	Standard Deviation NA	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Placebo	Month 12 (n=14,15)	88.99	Standard Deviation 16.63	ml/m^2
Left Ventricular End Diastolic Volume Indexed to Body Surface Area	Toprol XL	Month 12 (n=14,15)	95.71	Standard Deviation 20.59	ml/m^2

1 to 10 of 126Source ClinicalTrials.gov

See all 126 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	19
Overall Study	STARTED	Toprol-XL	19
Overall Study	COMPLETED	Placebo	18
Overall Study	COMPLETED	Toprol-XL	18
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Toprol-XL	1

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Placebo	1	19	1
other	Anemia	Blood and lymphatic system disorders	Toprol-XL	0	19	0
other	abdominal pain	Gastrointestinal disorders	Placebo	1	19	1
other	abdominal pain	Gastrointestinal disorders	Toprol-XL	0	19	0
other	anxiety	Psychiatric disorders	Placebo	1	19	1
other	anxiety	Psychiatric disorders	Toprol-XL	0	19	0
other	colon polyp removed	Gastrointestinal disorders	Placebo	0	19	0
other	colon polyp removed	Gastrointestinal disorders	Toprol-XL	1	19	1
other	headaches	Nervous system disorders	Placebo	1	19	1
other	headaches	Nervous system disorders	Toprol-XL	0	19	0

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Toprol-XL
Total, other adverse events	Placebo	6	19
Total, other adverse events	Toprol-XL	6	19
Total, serious adverse events	Placebo	7	19
Total, serious adverse events	Toprol-XL	4	19

Source ClinicalTrials.gov

Papers36

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1357162	BACKGROUND	PubMed
1734647	BACKGROUND	PubMed
3796056	BACKGROUND	PubMed
7911128	BACKGROUND	PubMed
8012639	BACKGROUND	PubMed
8184862	BACKGROUND	PubMed
9179087	BACKGROUND	PubMed
9277516	BACKGROUND	PubMed
9295005	BACKGROUND	PubMed
9593557	BACKGROUND	PubMed

1 to 10 of 36

See all 36 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Toprol-XL vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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